Introduction to Quality Control in Pharmaceutical Analysis

These flashcards cover key terms related to quality control in pharmaceutical analysis, providing definitions and essential information for exam preparation.

Quality Control (QC)

A tool that provides assurance that a product conforms to standards and specifications through inspection, analysis, and action.

Quality Assurance (QA)

The organized activities performed to ensure that all active pharmaceutical ingredients are of the required quality for their intended use.

Total Quality Management (TQM)

A management approach centered on quality, involving all members of an organization aiming for long-term success through customer satisfaction.

International Council for Harmonisation (ICH)

An organization that develops uniform standards for drug registration and promotes public health through international harmonization.

Accreditation

Quality assessment that determines if an organization meets the standards necessary to operate within a system.

Control Functions in Quality Control

Includes four categories: Analysis Function, Monitor Function, Record Review and Release Function, and Audit Function.

Benefits of Quality Control Systems

Includes minimizing product safety risks, ensuring regulatory compliance, guaranteeing product efficacy, reducing costs, and improving employee morale.

Standard Operating Procedure (SOP)

Documented process to ensure consistent quality in manufacturing and quality control activities.

Quality Control System

Combination of administrative and technical procedures established to produce and deliver safe, pure, and effective products.

Quality Control Divisions

Common divisions include Materials Inspection Section, Analytical Laboratory, Biological Testing Laboratory, Quality Coordination Office, and Specification and Analytical Development.